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Pilot to support ATMP research and development
Five academic and non-profit organisations developing advanced therapy medicinal products (ATMPs) will benefit from the European Medicines Agency’s (EMA) scheme.
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Committee for Medicinal Products for Human Use (CHMP)
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Ultomiris for generalised myasthenia gravis
The first and only long-acting C5 inhibitor, Ultomiris (ravulizumab), has been permitted in Europe for adults with generalised myasthenia gravis.
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EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
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EMA recommends RoActemra in adults with severe COVID-19
The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommends extending RoActemra's indication to include COVID-19 patients receiving systemic treatment.
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EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)
The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.
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CHMP issue positive opinion on Comirnaty® for five to 11 year olds
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
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EMA issues advice on use of Lagevrio for the treatment of COVID-19
The Europe Medicines Agency (EMA)'s human medicine committee advise (CHMP) that Lagevrio can be used for COVID-19 patients who do not require oxygen and are at increased risk.
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CHMP recommends COVID-19 vaccine Spikevax booster dose
The European Medicines Agency (EMA)'s human medicines committee (CHMP) concludes that a booster dose of Spikevax can be administered in adults aged 18 or over.
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CHMP initiates rolling review of molnupiravir for COVID-19
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
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Ronapreve™ reduces COVID-19 viral load within seven days
Phase II/III trial shows Ronapreve significantly reduced viral load in seronegative patients hospitalised with COVID-19, complimenting previous findings.
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EMA’s human medicines committee (CHMP) September meeting highlights
In its most recent meeting, the CHMP recommended nine new medicines and concluded its review of Vaxzevria’s thrombosis risk.
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EC approves Ultomiris for children and adolescents with PNH
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
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Comirnaty and Moderna COVID-19 vaccine supply to increase in the EU
The CHMP has adopted recommendations to increase manufacturing capacity and supply of COVID-19 Vaccines Comirnaty and Moderna in Europe.
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EMA’s human medicine committee (CHMP) meeting highlights, July 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
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EMA recommendations on compassionate use of remdesivir for COVID-19
The European Medicines Agency has released recommendations about which patients could benefit from remdesivir and the possible criteria for compassionate use of the drug.
